Immunology

ACAAI COVID-19 Task Force Members available to discuss allergic reactions to mRNA vaccines – Newswise

Niraj Patel, MD, MS, is Chief of the Division of Pediatric Infectious Disease and Immunology at Levine Childrens Hospital, in Charlotte, North Carolina. He is an Adjunct Associate Professor at the University of North Carolina Chapel Hill. Dr. Patel established the Charlotte Immunodeficiency Center of Excellence in 2009. He is board certified in pediatrics, pediatric infectious diseases, and allergy and immunology.

Dr. Patel chairs the American College of Allergy, Asthma and Immunology COVID-19 Task Force and is available to answer questions about allergic reactions to the mRNA COVID-19 vaccines.

Link:
ACAAI COVID-19 Task Force Members available to discuss allergic reactions to mRNA vaccines - Newswise

Immunology

Update on SOURCE Phase III trial for tezepelumab in patients with severe, oral corticosteroid-dependent asthma – PharmiWeb.com

AstraZeneca and Amgen today announced high-level results from the SOURCE Phase III trial which assessed the efficacy and safety of the potential new medicine tezepelumab compared to placebo in 150 severe asthma patients who required maintenance use of oral corticosteroids (OCS) on top of standard of care (SoC).

The 48-week trial did not meet the primary endpoint of a statistically significant reduction in the daily OCS dose, without loss of asthma control, with tezepelumab compared to placebo. Tezepelumabs effect on other efficacy parameters was similar to those observed in previous trials, including the registrational Phase III NAVIGATOR trial.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: Based on the totality of evidence, including the compelling exacerbation reduction results seen in the registrational NAVIGATOR Phase III trial and the PATHWAY Phase IIb trial, we remain confident that tezepelumab has the potential to improve care for a broad population of severe asthma patients. Our initial analysis of SOURCE in oral corticosteroid-dependent asthma indicates that the trial design may have contributed to the result of the primary endpoint. We are in the process of further analysing the data from SOURCE and look forward to sharing these results with the medical community.

The safety profile of tezepelumab in the trial was consistent with previous trials. Detailed results from the SOURCE trial will be presented at a forthcoming medical meeting.

On 10 November 2020, AstraZeneca and Amgenannouncedpositive results from the NAVIGATOR Phase III trial which met the primary endpoint and demonstrated a statistically significant and clinically meaningfulreduction in the annualised asthma exacerbation rate (AAER) in a broad population of patients with severe asthma, including those with low levels of eosinophils.

Tezepelumab is a potential first-in-class medicine that blocks the action of thymic stromal lymphopoietin (TSLP), an epithelial cytokine that plays a key role across the spectrum of asthma inflammation.1,2Tezepelumab is being developed by AstraZeneca in collaboration with Amgen.

Severe asthmaAsthma is a heterogeneous disease affecting an estimated 339 million people worldwide.3,4Approximately 10% of asthma patients have severe asthma,4,5which may be uncontrolled despite high doses of SoC asthma controller medicines and currently available biologic medicines. Some of these patients may require the use of long-term OCS4-6which can lead to serious short- and long-term adverse effects.7-9Severe, uncontrolled asthma is debilitating and potentially fatal, with patients experiencing frequent exacerbations and significant limitations on lung function and health-related quality of life.4,6,10Due to the complexity of severe asthma, many patients have unclear or multiple drivers of inflammation and may not qualify for or respond well to a current biologic medicine.5,11,12

PATHFINDER clinical trial programmeBuilding on the positive PATHWAY Phase IIb trial, the PATHFINDER Phase III programme includes the registrational NAVIGATOR trial and the supportive SOURCE trial.2,13-16The programme includes additional planned mechanistic and long-term safety trials.

SOURCE is a Phase III multicentre, randomised, double-blinded, parallel-group, placebo-controlled trial for 48 weeks in 150 adult patients with severe asthma who require continuous treatment with inhaled corticosteroids (ICS) plus long-acting beta2-agonists (LABA), and chronic treatment with maintenance OCS therapy.14,16In the trial, patients were randomised to receive tezepelumab 210mg every four weeks or placebo as add-on therapy, with patients maintained on their currently prescribed ICS plus LABA, with or without other asthma controller therapy.14,16

The primary efficacy endpoint was the percentage reduction from baseline in the prescribed daily OCS maintenance dose at 48 weeks while not losing asthma control. Secondary endpoints included the effect of tezepelumab on AAER, lung function, asthma control, quality of life, work productivity and activity impairment.14,16

NAVIGATOR is a Phase III, randomised, double-blinded, placebo-controlled trial in 1,061 adults (1880 years old) and adolescents (1217 years old) with severe, uncontrolled asthma, who were receiving treatment with medium- or high-dose ICS plus at least one additional controller medicine with or without oral corticosteroids. NAVIGATOR met the primary endpoint with tezepelumab added to SoC demonstrating a statistically significant and clinically meaningful reduction in the AAER over 52 weeks in the overall patient population, compared to placebo added to SoC. The trial also met the primary endpoint in the subgroup of patients with baseline eosinophil counts less than 300 cells per microlitre, with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER in that patient population. Similar reductions in AAER were observed in the subgroup of patients with baseline eosinophil counts less than 150 cells per microlitre.13,15,17

Patients who participated in the NAVIGATOR and SOURCE trials were eligible to continue in DESTINATION, a Phase III extension trial assessing long-term safety and efficacy.18

TezepelumabTezepelumab is a potential first-in-class human monoclonal antibody that inhibits the action of TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of allergic, eosinophilic and other types of airway inflammation associated with severe asthma.1,2TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles.1,2Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity.2,19Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control.2,19Tezepelumab acts at the top of the inflammation cascade and has the potential to treat a broad population of severe asthma patients regardless of their type of inflammation.2,19

AstraZeneca and Amgen collaborationEarlier in 2020, Amgen and AstraZeneca updated the2012 collaboration agreementfor tezepelumab. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid-single digit inventor royalty to Amgen. AstraZeneca continues to lead development and Amgen continues to lead manufacturing. All aspects of the collaboration are under the oversight of joint governing bodies. Under the amended agreement in North America, Amgen and AstraZeneca will jointly commercialise tezepelumab; Amgen will record sales in the US and AstraZeneca will record sales in Canada. AstraZenecas share of gross profits from tezepelumab in the US will be recognised as collaboration revenue. In all countries outside the US and Canada, AstraZeneca will solely commercialise tezepelumab. AstraZeneca will record all sales outside of the US as product sales and recognise Amgens share of gross profit as cost of sales.

AstraZeneca in Respiratory & ImmunologyRespiratory & Immunology is one of AstraZenecas three therapy areas and is a key future growth driver for the Company.

AstraZeneca is an established leader in respiratory care, and its inhaled and biologic medicines reached more than 53 million patients in 2019. Building on a 50-year heritage, the Company aims to transform the treatment of asthma and COPD by focusing on earlier biology-led treatment, eliminating preventable asthma attacks, and removing COPD as a top-three leading cause of death. The Companys early respiratory research is focused on emerging science involving immune mechanisms, lung damage and abnormal cell-repair processes in disease and neuronal dysfunction.

With common pathways and underlying disease drivers across respiratory and immunology, AstraZeneca is following the science from chronic lung diseases to immunology-driven disease areas. The Companys growing presence in immunology is focused on five mid- to late-stage franchises with multi-disease potential, in areas including rheumatology (including systemic lupus erythematosus), dermatology, gastroenterology, and systemic eosinophilic-driven diseases. AstraZenecas ambition in Respiratory & Immunology is to achieve disease modification and durable remission for millions of patients worldwide.

AstraZenecaAstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visitastrazeneca.comand follow the Company on Twitter@AstraZeneca.

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Update on SOURCE Phase III trial for tezepelumab in patients with severe, oral corticosteroid-dependent asthma - PharmiWeb.com

Immunology

GlaxoSmithKline/Vir’s and AstraZeneca’ mAbs eyed in early COVID-19 – pharmaceutical-technology.com

A second wave of monoclonal antibodies (mAbs) by GlaxoSmithKline/Vir Biotechnology and AstraZeneca hold scope to show comparable efficacy to FDA-authorised competitors in early COVID-19 disease, experts said. However, to differentiate they need to expand to other populations and settings, which depends on their design modifications translating to the clinic, they added.

The mAbs bid to differ or improve upon Eli Lilly and Regeneron Pharmaceuticals (NASDAQ:REGN) drugs, which were granted FDA Emergency Use Authorizations on 9 and 21 November, respectively, relies on Fc modifications. The mAbs must either improve efficacy in severe disease or have longer efficacy due to improved half-life.

Most experts still expect the second wave of mAbs to be similarly restricted to non-hospitalised, high-risk patients. Lackluster experience was observed in advanced COVID-19 disease due to inflammatory pathways playing a big role with Eli Lillys bamlanivimab and Regenerons casirivimab/imdevimab. While GSK/Virs VIR-7831 could succeed where others failed in this population, expectations remain uncertain as preclinical models remain ill-equipped to predict immune cell activity in patients with severe disease including the inflammatory pathways.

The longer half-life would be most relevant in the prophylactic setting and not provide any add-on as a treatment. However, as COVID-19 vaccines make headway, the potential for prophylactic mAbs is limited, as it is being restricted to immunocompromised, elderly patients or those who cannot receive the vaccine, experts said.

GSK/Virs programme consists of the Phase II/III (NCT04545060) COMET-ICE study for non-hospitalised patients, the National Institutes of Health (NIH)-led Phase III ACTIV-3 (NCT04501978) in hospitalised patients, and a planned prophylaxis or prevention of symptomatic infection trial in 1Q21. Interim data from COMET-ICE may be available as early as January 2021, with primary endpoint results in 1Q21, as per Virs 3Q20 earnings. The interim data is being viewed as a catalyst for the company, said an analyst. The analyst conservatively estimates USD 500m in peak sales for VIR-7831.

AstraZenecas cocktail AZD7442 is in two Phase III trials: PROVENT (NCT04625725) in the pre-exposure prophylaxis setting and STORMCHASER (NCT04625972) in the postexposure prophylaxis setting. Both have 2022 completion dates. No companies responded to requests for comment.

The authorised mAbs have limited efficacy data, but the investigational mAbs will have to show they can improve clinical outcomes in a similar manner to compete, said Dennis Burton, PhD, chair, Department of Immunology and Microbiology, Scripps Research Institute, La Jolla, California. Both bamlanivimab and casirivimab/imdevimab are authorised based on their ability to reduce viral loads and hospitalisations within 28 days after treatment. COMET-ICE is enrolling non-hospitalised patients at high risk of COVID-19 progression or who are ages 55 years and older, and its primary endpoint is driven by disease progression in a 29-day time frame. The COMET-ICE trial results will be closely watched to determine whether VIR-7831 can reduce viral replication and improve clinical outcomes, such as the need for hospitalisation in outpatients, compared to placebo, said a therapeutic antibody expert.

One clinical benefit with the authorised mAbs is seen in patients with milder disease and risk factors like old age and comorbidities, said Michael Diamond, PhD, associate director, Center for Human Immunology and Immunotherapy Programs, Washington University School of Medicine at St Louis. Despite preclinical animal data with GSK/Vir and AstraZenecas mAbs proving activity, comparisons between the authorised and investigational mAbs in terms of superior or similar efficacy cannot be made conclusively without clinical data, said Dimiter Dimitrov, PhD, director, Center for Antibody Therapeutics, University of Pittsburgh Department of Medicine, Pennsylvania.

Generally, experts expected the most efficacy potential in the non-hospitalised setting. The challenge with late delivery is how the disease is being driven by an inflammatory response at the time of hospitalisation, when the mAbs ability to decrease the viral loads becomes a moot point, Diamond added. As vaccines become more widely available, the bar for antibody treatments will become higher as fewer patients get sick, said the antibody expert. Still, more treatment options are needed for severe COVID-19 patients, so it may be a good idea to evaluate whether modified mAbs may work later in the disease, said Diamond.

GlobalData's TMT Themes 2021 Report tells you everything you need to know about disruptive tech themes and which companies are best placed to help you digitally transform your business.

On 23 December, the NIH announced the preliminary results from ACTIV-3, which showed Eli Lillys bamlanivimab failed to provide clinical benefit in hospitalised COVID-19 patients. The study was initially studying bamlanivimab in this setting, but stopped after a Data Safety Monitoring Board noted no clinical benefit in patients treated with the mAb, as per a 26 October announcement. On 30 October, Regeneron halted enrolment in its own hospitalised patient study for patients on high-flow oxygen or mechanical ventilation, but continued enrolling those who require either no or low-flow oxygen.

While Regeneron and Eli Lilly did not make any Fc modifications in their mAb therapies, GSK/Vir and AstraZeneca have done so. VIR-7831s differentiated Fc effector function, which is designed to recruit macrophages and natural killer cells, could be studied in hospitalised patients, a second analyst noted prior to the ACTIV-3 trial inclusion announcement. On 17 December, Vir announced the first patient had enrolled in the ACTIV-3 trial to evaluate VIR-7831s impact on time to recovery among other endpoints.

Recruiting effector cells like natural killer cells and macrophages may be helpful in advanced COVID-19, but there is a risk they could kill normal cells in the lung as well, which could cause further damage, said Dimitrov. Moreover, it is not yet clear whether a mAb blocking the target is preferable for efficacy over a mAb modified to target the immune cells as well, said an immunology expert.

However, information on effector immune cells in animal models can be limited, so predicting effector function in humans based on the preclinical data is difficult, said Burton. VIR-7832 is a GAALIE-engineered mAb. In a mouse model, data demonstrated the selective engagement of an activating Fc receptor on dendritic cells by anti-influenza GAALIE-engineered antibodies induced protective CD8+ T cell adaptive responses (Bournazos, S., et al,. Nature 588, 485490 (2020).

COMET-ICE is a placebo-controlled study. However, once the authorised mAbs are FDA approved, noninferiority studies comparing those to the next investigational mAbs will need to be designed to prove they are clinically equivalent or have significant efficacy in preventing progression to severe disease, said Diamond. VIR-7831 is engineered to potentially enhance lung bioavailability and have an extended half-life. AZ-7442s potential to protect people for six months or more and could work as a therapeutic, the first analyst noted. Since the virus clears within 1421 days, it is not clear if the longer half-life will be an issue in the treatment setting, Diamond said. The extended half-life may be an important feature in mAb prophylactics for those at high-risk who cannot get vaccinated, he added. While mAbs can be used as a prophylactic in the elderly or immunocompromised population, the current vaccines are very effective, said Dimitrov.

Another benefit for Fc modification is how it offers a greater degree of efficacy against potential resistant viral strains. A new variant strain of SARS-CoV-2 called B.1.1.7, which contains a series of mutations including one in the receptor binding domain of the viral spike protein, has been described in the UK this month and is said to be more rapidly transmissible than other strains. If there are mutations leading to new variants, specifically those incapable of being neutralised by a particular mAb, they could be targeted by others, said Dimitrov. The efficacy of monotherapy versus combination in the context of resistance would then depend on the individual mAbs target region and if the escape mutations are noted there, said Diamond.

Manasi Vaidya is a Senior Reporter for Clinical Trials Arena parent company GlobalDatas investigative journalism team. A version of this article originally appeared on the Insights module of GlobalDatas Pharmaceutical Intelligence Center. To access more articles like this,visit GlobalData.

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28 Aug 2020

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GlaxoSmithKline/Vir's and AstraZeneca' mAbs eyed in early COVID-19 - pharmaceutical-technology.com

Genetics

COVID-19 severity could be linked to genetic variance – News-Medical.Net

The extent of the coronavirus disease 2019 (COVID-19) pandemic is staggering. Among the worst aspects of the disease is the immense uncertainty about the clinical course, with some developing severe or critical COVID-19, and often dying of it, while others remain asymptomatic or have only mild symptoms throughout. A new preprint appearing on the medRxiv* server in December 2020 describes some potentially important genetic factors in the host that may shape the clinical symptoms and signs of the disease.

A recent study reported the outcome of a genome-wide association study (GWAS) that showed two genetic loci possibly linked to increased susceptibility to the disease process. The first was on chromosome 3, encoding a number of genes that may have a functional role in COVID-19 disease. The second was on chromosome 9, which also harbors the ABO blood group. A second recent study demonstrated the presence of uncommon gene mutations in the type I interferon pathway that contribute to the risk of serious or critical pneumonia in COVID-19. Even more recently, two separate GWAS reports showed evidence that the first two susceptibility loci were actually associated with high risk for serious disease. These studies also identified new variants on severe loci on chromosomes 19, 12 and 21 that were linked to severe COVID-19.

The current study aimed to explore the possibility that there are some variants on certain loci on chromosome 21 near the genes that encode TMPRSS2 and MX1. They examined GWAS data from the COVID-19 Host Genetics Initiative, and mapped chromosome 21 in deep mapping. They found that, indeed, commonly found variants were significantly associated with severe COVID-19.

In a large cohort of over 908,494 individuals, from Europe, the researchers found five single nucleotide polymorphisms (SNPs) at the TMPRSS2/MX1 locus, which were associated with less severe disease. The cohort included ~6,400 severe cases and over 9,00,000 controls. The same association was found in two Asian cohorts, with all five SNPs, and two and one SNPs were confirmed in African and Italian cohorts, respectively.

Using the expression quantitative loci (eQTL) parameter to assess the relationship between the gene variants and gene expression, of the most significantly disease-associated SNPs, they found that all the top five SNPs showed eQTL signals for MX1 in the blood. The minor alleles of these variants, the gene less often expressed, was correlated with higher MX1 levels. MX1 is a guanosine triphosphate (GTP)-metabolizing protein that takes part in cellular antiviral responses, inhibiting viral replication. It is induced by both type I and III interferon pathways.

Of the other SNPs, 9/14 did not show such signals, except for one. The minor alleles of 4/5 SNPs also correlated inversely with TMPRSS2 expression. One of these minor alleles is, in addition, an eQTL for TMPRSS2 in osteoblasts following treatment with dexamethasone.

The uncovering of host genetic factors that may explain the marked differences in COVID-19 clinical features is important, not just to understand the pathogenesis of the disease, but also to identify therapeutic targets that will respond to drugs. Human host cells express both angiotensin-converting enzyme 2 (ACE2) as well as the transmembrane serine protease TMPRSS2. The authors postulated that genetic variants with both reduced TMPRSS2 and higher MX1 may be connected with a better outcome following SARS-CoV-2 infection.

Enrichment of SNPs in regulatory regions and eQTL analyses. The statistically significant fold enrichments (P<0.05 after Bonferroni correction) of SNPs in regulatory DNA regions active in different tissues are shown (a). eQTL violin plots between genotypes of rs3787946 (b) and rs3787946 (c) with MX1 and TMPRSS2 expression from the from the Genotype-Tissue Expression (GTEx).

Not only did these five SNPs show a high frequency, but minor alleles were far less common among more severe cases, suggesting they play a protective part. The reproducibility of these SNPs in multiple cohorts suggests that the q22.3 locus on chromosome 21 is a novel susceptibility locus to unfavorable outcome of COVID-19 and suggest that molecular mechanisms underlying this genetic predisposition may be common among individuals with different ethnicity.

The SNPs here are enriched in the regions that regulate pluripotent stem cells and thymus. The latter is connected to adaptive immunity, but undergoes functional waning with age. The inflammatory tendency associated with immune senescence of aging is a key factor in many immune responses. It is significant that both aging and inflammatory age-related diseases are associated with severe COVID-19. The association of these gene variants with a dysfunctional thymus could be another explanation for this link with severe COVID-19.

The findings also show that MX1 is possibly related to the clinical phenotype in COVID-19, supporting the conclusions of a recent study that suggests this molecule is an effector against SARS-CoV-2. Other supportive findings include a higher MX1 expression in infected individuals and in those with higher viral loads. The MX1 levels are lower with advancing age.

Mutations that inactivate the type I interferon pathway are recurrent in COVID-19 patients. In this light, the current study supports the evidence that the use of drugs, activating IFN signaling, could be an effective treatment to prevent the adverse outcome of disease. While type I or III interferons are being used in clinical trials to prevent or treat COVID-19, they may enhance or induce a cytokine storm with deadly results. Thus, it is highly relevant to spawn new drugs that have the capacity to boost the host immune response while controlling tissue damage.

The rs12329760 coding variant is found to be linked to lower TMPRSS2 in osteoblasts following dexamethasone treatment. This drug is a powerful anti-inflammatory. This variant is uncommon among Chinese COVID-19 patients with critical illness. Modeling predicts that it may reduce viral entry into the cells by destabilizing TMPRSS2 and ACE2 binding. Thus, these SNPs may impact the functions of TMPRSS2 as well. Uncovering the functions of these MX1-regulatory gene variants may be of great help in initiating new therapeutic avenues for this lethal condition.

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COVID-19 severity could be linked to genetic variance - News-Medical.Net

Genetics

Insights on the Genetic Testing Global Market (2021 to 2025) – Updated for COVID-19 Pandemic Impact – GlobeNewswire

Dublin, Dec. 21, 2020 (GLOBE NEWSWIRE) -- The "Genetic Testing. Global Market Forecasts for Applications and Technologies. Updated for COVID-19 Pandemic Impact with Executive and Consultant Guides 2021 to 2025" report has been added to ResearchAndMarkets.com's offering.

The role of genetics in health and disease is just now being understood. This new knowledge, combined with lower pricing is driving the Genetic Testing industry to record growth. New drugs may only work for people with a certain genetic makeup, and this too is driving the Genetic Testing Industry.

The traditional genetic testing market is growing in volume and growing in the breadth of tests creating a new life for the industry. The report forecasts the market size out to 2025. The report includes detailed breakouts for 14 countries and 5 regions.

Predictive Diagnostics? Pharmacogenomic Testing? Direct to Consumer? Find out about the technology in readily understood terms that explain the jargon. What are the issues? Find the opportunities and the pitfalls. Understand growth expectations and the ultimate market forecasts for the next five years.

Key Topics Covered:

Genetic Testing - Strategic Situation Analysis & Impact of COVID-19 Pandemic

1. Introduction and Market Definition 1.1 Genetic Testing Definition in This Report 1.2 The Genomics Revolution 1.3 Market Definition 1.3.1 Revenue Market Size1.3.1 Newborn Screening 1.3.2 Non Invasise Pregnancy Testing 1.3.3 Predictive 1.3.4 Oncology 1.3.5 Direct to Consumer 1.3.6 Other Application1.3.7 PCR 1.3.4 NGS 1.3.5 Cytogenetic1.3.6 Other Technology 1.4 U.S. Medical Market and laboratory Testing - Perspective 1.4.1 U.S. Medicare Expenditures for Laboratory Testing

2. Market Overview 2.1 Market Participants Play Different Roles 2.1.1 Supplier/pharmaceutical 2.1.2 Independent lab specialized/esoteric 2.1.3 Independent lab national/regional2.1.4 Independent lab analytical 2.1.5 Public National/regional lab 2.1.6 Hospital lab 2.1.7 Physician lab 2.1.8 DTC Lab2.1.9 Independent Genetic Testing Lab2.1.10 Audit Body2.2 Genetic Tests -Types, Examples and Discussion 2.2.1 Preimplantation Genetic Diagnosis- An Emerging Market 2.2.2 Prenatal Diagnosis - New Technologies Create Opportunity 2.2.3 Newborn Screening 2.2.2 Diagnostic Testing 2.2.3 Carrier Testing 2.2.6 Predictive and Presymptomatic Testing 2.2.7 Pharmacogenomics 2.2.8 Forensic Testing2.2.9 Parental Testing 2.2.10 Ancestral Testing2.3 Industry Structure 2.3.1 Hospital's Testing Share 2.3.2 Economies of Scale2.3.2.1 Hospital vs. Central Lab 2.3.3 Physician Office Lab's 2.3.4 Physician's and POCT 2.4 Market Shares of Key Genetics Players - Analysis

3. Market Trends3.1 Factors Driving Growth3.1.1 Genetic Discoveries Creating New Diagnostic Markets 3.1.2 Aging Population a Boon for Diagnostics3.1.3 Pharmacogenomics Drives Further Growth3.1.4 Oncology and Liquid Biopsy Enter New Era3.1.5 Fertility Practice Growth drives market 3.1.6 Direct to Consumer begins to break out 3.2 Factors Limiting Growth3.2.1 Increased Competition Lowers Price 3.2.2 Lower Costs3.2.3 Testing usage analysis curtailing growth3.2.4 Wellness has a downside 3.3 Instrumentation and Automation 3.3.1 Instruments Key to Market Share 3.3.2 Bioinformatics Plays a Role3.4 Diagnostic Technology Development3.4.1 Next Generation Sequencing Fuels a Revolution3.4.2 Impact of NGS on pricing 3.4.3 POCT/Self Testing Disruptive Force3.4.4 Pharmacogenomics Blurs Diagnosis and Treatment 3.4.5 CGES Testing, A Brave New World 3.4.6 Biochips/Giant magneto resistance based assay

4. Genetic Testing Recent Developments4.1.1 Importance of This Section 4.1.2 How to Use This Section

5. Profiles of Key Companies

6. Global Market Size6.1 Global Market by Country 6.1.1 Table - Global Market by Country6.1.2 Chart - Country Market Shares 6.2 Global Market by Application 6.2.1 Table - Global Market by Application 6.2.2 Chart - Application Share by Year 6.2.3 Chart - Application Segment Growth Rates 6.2.4 Chart - Application Segment Share Shifts6.2.5 Chart - Application Segment Share Base Year 6.2.6 Chart - Application Segment Share Final Year 6.3 Global Market by Technology 6.3.1 Table - Global Market by Technology 6.3.2 Chart - Technology Share by Year 6.3.3 Chart - Technology Segment Growth Rates 6.3.4 Chart - Technology Segment Share Shifts6.3.5 Chart - Technology Segment Share Base Year 6.3.6 Chart - Technology Segment Share Final Year

7. Market Sizes by Application 7.1 Newborn Testing Market 7.1.1 Table Newborn - by Country7.1.2 Chart - Newborn Growth 7.2 NIPT Market 7.2.1 Table NIPT - by Country 7.2.2 Chart - NIPT Growth 7.3 Predictive Testing Market7.3.1 Table Predictive - by Country 7.3.2 Chart - Predictive Growth 7.4 Oncology Testing Market7.4.1 Table Oncology - by Country 7.4.2 Chart - Oncology Growth 7.5 DTC Testing Market 7.5.1 Table DTC - by Country 7.5.2 Chart - DTC Growth 7.6 Other Testing Market 7.6.1 Table Other - by Country 7.6.2 Chart - Other Growth

8. Global Genetic Testing Market by Technology 8.1 PCR Testing Market 8.1.1 Table PCR - by Country 8.1.2 Chart - PCR Growth 8.2 NGS Market 8.2.1 Table NGS - by Country8.2.2 Chart - NGS Growth8.3 Cytogenetic Testing Market 8.3.1 Table Cytogenetic - by Country8.3.2 Cytogenetic - Predictive Growth 8.4 Other Testing Market 8.4.1 Table Other - by Country 8.4.2 Chart - Other Growth

9. The Future of Genetic Testing

10. Appendices

For more information about this report visit https://www.researchandmarkets.com/r/z52i9s

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Insights on the Genetic Testing Global Market (2021 to 2025) - Updated for COVID-19 Pandemic Impact - GlobeNewswire

Genetics

Diversifying the pack: Cross fostering helps Mexican wolf population boost genetic mix – Arizona Daily Star

The center has led the Mexican wolf cross-fostering program that began in 2014. Founded in 1971, it sits on 63 isolated, wooded acres, designed to match the cold, silent and humanless habitat where Mexican wolves live.

Through cross-fostering, 8- to 14-day-old pups born in captivity are placed in a den of similar-aged wild pups in remote areas of the Southwest.

Being able to take puppies from facilities like the Endangered Wolf Center and sneaking them into wild litters is a great way for us to be able to get new genetics out into the wild to help keep that wild population healthier, said Regina Mossotti, director of animal care and conservation at the Endangered Wolf Center.

Mexican wolves breed in April and May, leaving a narrow window for cross-fostering.

To successfully cross-foster a wolf pup, officials must identify a wild wolf that has given birth about the same time that a female wolf in captivity at the center gives birth.

When that does happen, the clock starts ticking.

We have to be able to find a flight, the weather has to work and we have to have enough people to do it, Mossotti said. So all these things, these logistics have to come together to make it happen.

Once the team from the Endangered Wolf Center arrives in Arizona, Game & Fish employees join them on a hike to a specific wolf den, often hidden in the rugged terrain along the Arizona-New Mexico state line.

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Diversifying the pack: Cross fostering helps Mexican wolf population boost genetic mix - Arizona Daily Star

Anatomy

Grey’s Anatomy: 10 Saddest Things About Derek | ScreenRant – Screen Rant

Grey's Anatomy's Derek Shepherd may come across as pompous and arrogant, but this is a facade to hide his tragic backstory.

Over the years, fans have been introduced to so many interesting characters on Grey's Anatomy. Some ended up tugging at our heartstrings more than others, and perhaps the one character that everyone had trouble letting go of was Derek Shepherd - the love of Meredith's lifethat left this world too soon.

RELATED:Grey's Anatomy: 10 Major Relationships, Ranked From Weakest To Strongest

While he was alive and working at Grey Sloan Memorial, there was a lot to love about Derek. There was also a lot of sadness and strife surrounding him and his life. Derek is a deeply flawed and complex individual, yet Meredith loved him regardless. Here are just some of the saddest things about everyone's handsome, maybe-misunderstood, and often wayward doc.

Viewers never even knew a Derek who didn't have fidelity issues. Derek's inability to stay true to the person he has committed to is a serious character flaw. He cheated on Addison with Meredith and then cheated on Meredith with his assistant in DC. His serial cheating is simply sad, especially considering how much Meredith loved him, flaws and all.

The sparks had already flown when Grey's Anatomy viewers discovered that Meredith's McDreamy was married. His wife Addison was back in New York while Derek was out in Seattle talking up Meredith like he didn't have a care in the world. Meredithwas clearly Derek's forever person, and he and Addison were never meant to be. While Derek ended up with the woman made for him, divorce is still a sad circumstance to go through - especially as it meant ending an eleven-year relationship.

One of the most emotional and intense moments that the show ever saw was when an active shooter took over the hospital that Derek and the other surgeonsworked at. As fans remember, the season 6 finale sawDerek placed in immortal danger whenGary Clark returned to the hospital to enact his revenge. Derek spent most of the episode ensuring that everyone was safe.

RELATED:Grey's Anatomy: Meredith's 10 Most Emotional Quotes, Ranked

However, it wasn't long before he ran into Gary Clark, who proceeded to shoot him in front of Meredith. The doctors are able to save him, but this moment took every viewers' breath away.

Derek has displayed issues with fidelity since fans first met him. However, it didn't take long to discover the reasons why he had these insecurities. As fans remember, Addison arrived in Seattle at the end of season 1 and revealed that she was married gave Derek.

After seeking him out, Meredith later learned that Addison had cheated on him with his childhood best friend. There was no excuse for him keeping it a secret from Meredith, but the fans did sympathize with the fact that he was betrayed by the two people he trusted most.

Seeing terrible things happen to your parent would do a number on anyone, and sadly Derek saw his father lose his life. As many fans remember, Derek's dad owned a shop, which Derek and Amelia hung out in frequently.

While they were there, the shop eventually got robbed. Since Derek's father refused to give up the watch, it eventually cost him his life. To make matters worse, Derek had witnessed it all as he had been hiding in the back with Amelia. One has to wonder how that shaped Derek as an adult.

Derek Shepherdand Meredith have had a relationship that seemed to have been tested at every possible turn. One of those many tests came in the sixth season when Meredith discovered that she was expecting Derek's baby.

RELATED:Grey's Anatomy: April's 10 Best Episodes, Ranked

Sadly, their joy was short-lived. Meredith suffered from a miscarriage because of the severely stressful events surrounding the pair. The aftermath of the loss was massive and stayed with the couple for years.

Back in season 11, fans were taken by surprise when they witnessed Derek's car get hit by a truck. Instead of going to Grey Sloan, Derek ends up arriving at a hospital that does not have good resources or medical expertise. The surgeons also don't seem aware of his reputation either.

What makes the situation even worse was that Derek could not speak or tell them what was wrong. As a result, he passes as a result of his injuries. Not only does Meredith have to turn his life support off but she also realizes that the hospital's negligence cost Derek his life.

Fans have seen so many characters on Grey's Anatomy pass on. At least favorites, like George, had friends working on them, trying to save their lives. Poor Derek didn't have this luxury. The professionals who received his battered body didn't know him. They weren't his friends.

In the end, Derek was alone in his final hours. Even for someone who had seen so much loss in his life, leaving Earth like this had to be terribly scary and difficult. What was more tragic was that Derek's family didn't even get a chance to say goodbye - which was something he wished for in "The First Cut Is the Deepest."

Derek and his sister Amelia have an interesting relationship. Derek hasn't always been supportive of Amelia, and even seems insecure and jealous of her talents when she came to work in Seattle.

RELATED:Grey's Anatomy: Amelia Shepherd's 10 Most Heartbreaking Moments

That said, he was there for her when she needed help. When Amelia overdosed and was gone for roughly three minutes, Derek was the one who had to resuscitate her. While Amelia got help and sobered up, it was clear that this trauma had deeply affected him and their relationship.

Derek and Meredith really had to fight for their relationship. There were times that they broke up, and other times where there were infidelity and secrets between them. Nevertheless, they managed to pull through, get married, and start a family.

The pair had two children and a third on the way when Derek suddenly passed away. However, Derek never had the chance to meet Ellis as Meredith was unaware that she was pregnant when his accident occurred.

NEXT:Grey's Anatomy: 10 Things That Make No Sense About The Patients

Next Grey's Anatomy: 10 Most Overdone Storylines

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Grey's Anatomy: 10 Saddest Things About Derek | ScreenRant - Screen Rant

Anatomy

Patrick Dempsey will be back on ‘Grey’s Anatomy’… again – The Star Online

Grey's Anatomy has been tackling coronavirus for the entirety of Season 17, and although the pandemic has inspired intense storytelling that mirrors the real state of the world, the medical drama also had a major boost of brightness recently with the return of Patrick Dempsey's Derek Shepherd.

The beloved character, who was killed off in Season 11 after a fatal car crash, appeared in Meredith Grey's (Ellen Pompeo) dreams, as she was fighting Covid-19 from her hospital bed.

Shepherd, better known as "McDreamy," surprised fans with the appearance earlier in the season, showing up on a beach in Meredith's dreams.

But, good news for "Grey's Anatomy" fans: McDreamy will be back again.

"You will see McDreamy again in the back half of the season," says showrunner Krista Vernoff.

Other than confirming Derek's return in the episodes airing in 2021, Vernoff is staying mum on who else might make an appearance.

But she is hopeful to recruit more of the actors who used to star on the medical drama, which has seen a number of characters die over the past 17 seasons.

"We all have hopes, but we don't have anything new to report yet," Vernoff adds.

When asked specifically about Eric Dane's character, Mark Sloan, otherwise known as "McSteamy," one of the all-time fan-favourite characters in Grey's Anatomy history who was killed in a plane crash at the beginning of Season 9, Vernoff laughs,"You can ask, but I can't answer!"

Will fans be able to see McSteamy (Eric Dane, left) as well this season?

At the time of Dempsey's return, social media erupted with excitement, and a screenshot from IMDb.com was floating around Twitter, circulated by fans.

The image appeared to show that many former Grey's actors including Katherine Heigl, Sandra Oh, Jeffrey Dean Morgan, Sara Ramirez and more were billed as part of the current season, causing fans to theorise that those characters would possibly show up in Meredith's dreams.

Vernoff has seen the screenshot on social media, but says the information is incorrect.

"My stepson sent me that picture, and my answer was, 'Oh my god! I wish!' But no," Vernoff says.

"No, no, that's not that was some glitch on IMDb."

With a laugh, she lovingly pokes fun at the show's devoted audience, adding,"Debbie Allen said to me, 'They're so greedy! You just gave them McDreamy!'"

Grey's Anatomy is the longest-running medical drama in television history, having surpassed ER.

The show has not been renewed for an 18th season yet, though it remains one of ABC's top-rated shows, a stunning victory for any series, let alone one so far along in its TV life.

Creator Shonda Rhimes has said on multiple occasions that she will end the show whenever Pompeo is ready to call it quits.

Pompeo, who serves as a producer, has starred as the show's titular character since it premiered in 2005.

Her contract is up this year, but earlier this fall Pompeo told Variety that no one knows when the show will sign off.

"We don't know when the show is really ending yet. But the truth is, this year could be it," Pompeo recently said.

"I'm constantly fighting for the show as a whole to be as good as it can be. As a producer, I feel like I have permission to be able to do that. I mean, this is the last year of my contract right now. I don't know that this is the last year? But it very well could be."

The doctors and nurses at Grey Sloan Memorial Hospital Grey's Anatomy have been tackling coronavirus.

During an interview about last night's midseason finale, when asked about the future of the show, Vernoff also said she was unsure when Grey's Anatomy will ultimately end.

"'I don't know' is the honest answer," Vernoff says. "I don't know. And so, I planned a phenomenal season, and I've planned what can be a season finale or what could be a series finale."

"I never really believe it's really over until everybody sits me down they're all going to have to come together and sit me down and tell me it's really over," Vernoff continues.

"But you always have to plan for both contingencies.

"We have a plan for how the season is going to end, and I feel really good about that plan, but I will say that at this point in any given season, we usually have a plan for where the season is going to end and it doesn't always end where we think it will. So, you never know." Reuters

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Patrick Dempsey will be back on 'Grey's Anatomy'... again - The Star Online

Anatomy

Surgeons in Ireland mistakenly operated on the wrong side or incorrect anatomy 63 times since 2017 – Irish Mirror

Surgeons have mistakenly operated on the wrong side or incorrect anatomy 63 times since 2017, HSE figures revealed.

Cases included the removal of a boys healthy left kidney instead of his poorly functioning right at Our Ladys Childrens Hospital in 2008.

Records show the number of wrong-site procedures increased in each of the past three years, from 15 in 2017 to 22 last year.

The Irish Patients Association has demanded an explanation for the rise in wrong-site surgeries, which are categorised as never events because they are wholly preventable and should not happen.

Spokesman Stephen McMahon said: The actions required to minimise the chance of a wrong leg or organ being operated on are known, and the increase in these events must be explained by those who are responsible. A further seven botched surgeries were recorded in four public hospitals in the first 10 months this year.

The data does not include voluntary hospitals, which are not owned by the State but are predominantly funded by the HSE. With eight since 2017, Cork University Hospital saw the most wrong-site surgeries.

Seven were recorded at Our Ladys Hospital in Navan in the same period, while six occurred at Midland Regional Hospital in Tullamore.

Fewer than five wrong-site surgeries were performed at 17 other facilities including University Hospital Galway, University Hospital Limerick, Letterkenny University Hospital, and St. Lukes General Hospital in Kilkenny.

Cork University Hospital and Our Ladys Hospital in Navan, recorded at least one botched op in each of the years between 2017 and 2020.

The data was extracted from the National Incidents Management System, which is hosted by the State Claims Agency.

It was released by the HSE under freedom of information laws.

A spokeswoman for the HSE said systems were in place to identify, manage and address incidents that arise in delivering healthcare.

She added: All incidents are identified, reported and reviewed so learning from events can be shared to improve the quality and safety.

Services are continually engaged towards identifying areas where incidents are likely and putting in place systems to prevent or reduce the likelihood of the risk of occurrences.

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Surgeons in Ireland mistakenly operated on the wrong side or incorrect anatomy 63 times since 2017 - Irish Mirror

Embryology

The Impact of COVID-19 on the Fertility Sector – BioNews

21 December 2020

'What a year it's been!' With this statement, Sarah Norcross, director of the Progress Educational Trust (PET) opened the charity's annual conference 'Fertility, Genomics and COVID-19' on 9 December which, for the first time in its history, was online via Zoom.

She spoke about how the COVID-19 pandemic has 'affected the lives of all of us', and this was inevitably the unexpected theme of this year's conference. The plus side of holding a virtual conference was that half of this year's speakers were able to attend from overseas, said Norcross, speaking from her kitchen. She added that this year she did not have to worry about the conference catering, or queues for the loos, but rather whether delegates would hear the sound of her husband putting the kettle on.

Norcross also announced the appointment of Professor Dame Lesley Regan as a new patron of PET (which publishes BioNews).

The first session 'The Impact of COVID-19 on the Fertility Sector', chaired by Norcross, heard from three heavyweights and chairs of different organisations.

First to speak was Sally Cheshire, chair of the UK's Human Fertilisation and Embryology Authority (HFEA) and interim chair of the Children and Family Court Advisory and Support Service (CAFCASS).

The UK regulator will reach its 30-year anniversary in 2021, and she examined the role of the HFEA and how it has and will regulate fertility services through the pandemic and beyond. Cheshire said that fertility clinics in the UK shut their doors for the first time in 30 years on 15 April this year, in response to the Government's directive. 'It was the most challenging decision we had to make in 30 years,' she said.

Patient safety was paramount. And with this in mind, clinics stopped new treatments from 23 March, though fertility preservation treatments (eg for patients undergoing chemotherapy) have continued throughout the pandemic. Other issues that the HFEA had to consider with the upheaval caused by COVID-19 and lockdown included the 10-year storage limits for gametes, and patients who were approaching the cut-off age of fertility treatment on the NHS.

At the height of the pandemic in the spring, NHS fertility staff including anaesthetists and nurses, as well as laboratory testing equipment were turned over to help tackle COVID-19. In the private fertility sector, many staff were furloughed and the industry lost millions of pounds. She said there are normally about 6000 IVF cycles worth 30 million in one month alone.

'The worries about whether these businesses would survive were real ones,' Cheshire told delegates. Additionally, staff 'were undergoing what everybody else' was, with sickness and the loss of colleagues and loved-ones to COVID-19.

For patients there were many questions about treatment and waiting lists. Cheshire said that the technical NHS term 'non-emergency' applied to fertility treatments provoked some anger among patients on social media. Patients' worries about the 10-year storage limit for gametes were addressed by the UK government with a two-year extension given to those affected by the pandemic (see BioNews 1040).

The fertility sector was the earliest sector to reopen on 11 May, said Cheshire. Many adjustments have been made, including in the HFEA's own processes such as the video assessments of clinics.

On a different note, she said the HFEA has extended its own strategy to 2024, and are in discussions on changes to the Human Fertilisation and Embryology (HFE) Act. But Cheshire cautioned: 'Warnock two might be a long way off.'

Following on from this, Dr Jane Stewart gave her clinician's perspective on the pandemic. Chair of the British Fertility Society, Dr Stewart made it clear that she was speaking from her experiences as head of the Newcastle Fertility Centre.

She said her Trust already had a pandemic policy in place. So when the Government directive came to close all centres: 'There was no time for panic, we had to start planning.' All elective and non-emergency work was stopped, staff redeployed, and many worked from home.

'Patient communication was an enormous part of it,' she said. 'We didn't always get that right but certainly it was a priority for us.'

Once their clinic reopened, they re-established appointments via phone calls or video-link, and would bring patients in separately for their physical assessments. 'We scrutinised all treatment protocols to reduce the number of visits,' said Dr Stewart.

She welcomed the vaccine news on COVID-19, as 'things beginning to turn a corner'. However, she also noted that a 'big dilemma' would be coming up for fertility patients as there is no data on use of the vaccine in pregnant women, so it is currently not advised in this group.

'Hopefully, there will be some discussion around this,' she said.

Dilemmas were the focus of the next speaker, Julian Savulescu, professor of practical ethics at the University of Oxford and director of the Oxford Uehiro Centre for Practical Ethics. 'IVF, in general, is a playground of ethical issues with many questionable policies and regulatory issues,' he said.

He shared some of his work on ethics and COVID-19, reflecting on how this might be applied to dilemmas in fertility treatment.

'It seems to me that the challenges facing people with infertility are the challenges facing all of us during the pandemic,' said Professor Savulescu.

These include the trade-offs between liberty and wellbeing, in particular, that of the infertile versus the health of the elderly; policies of selective restriction of freedom; and in the allocation of limited resources, how we balance equality versus utility. The comparisons were particularly pertinent in how limited resources such as ventilators, vaccines or IVF are allocated.

The principle of equality or egalitarianism is 'equal treatment for equal need' (one of the NHS's basic principles), which means that factors such as potential length of life gained and the probability and quality of survival would be ignored in allocating resources.

Healthcare decisions based on utility or utilitarianism allocate according to what will bring the greatest benefit. This approach would take into account for example, the quality and predicted length of survival when allocating a ventilator to a COVID-19 patient.

Many governments use QALYs (cost per quality-adjusted life year) which estimate how much benefit is gained for the cost, to make healthcare utilitarian decisions. Professor Savulescu noted that for the UK's pandemic lockdown response, the QALYs were 'enormous'. He said that the prioritisation of IVF inside and outside the pandemic is a massive value assumption depending on how you value the life of a subsequent child (IVF calculations do not typically include QALYs for the child).

While the UK did not use utilitarian decision-making in pandemic allocations, for example NICE and the Intensive Care Society used frailty rather than QALYs to allocate ventilators, such principles guide some IVF allocations. For example, an IVF age-cut off that 'may well' also breach the UK's Equality Act 2010. Likewise, in Australia, BMI limits are placed on IVF.

Professor Savulescu noted contestable ethical issues arising from the pandemic itself. Early on in the pandemic it became apparent that the disease primarily kills the elderly, he said.

Modelling by the US Centres for Disease Control and Prevention in November suggested the chance of someone aged 20-49 dying from COVID-19 lay somewhere between 7 in 100,000 and 2 in 10,000. He said the chances of a person in this age group the IVF patient age group, dying in a car accident are 1 in 10,000.

With such a low risk, the primary reason for stopping IVF during the pandemic is to prevent transmission. 'Then the issue is can we use PPE to prevent transmission?' asked Professor Savulescu.

He wrapped up by saying that patients with infertility have been a low priority whose 'liberty has probably been excessively restricted' and raised questions about them being given greater priority now.

As usual with PET events, the second half of the session was given over to audience questions. Cheshire was asked about the potential to reopen the HFE Act to bring it up to date. She agreed that it would be beneficial to review some areas, but acknowledged that Parliamentary time is likely to be taken up with COVID and Brexit. One of the areas she and Dr Stewart spoke about was the extra level of confidentiality surrounding fertility treatment, meaning that it does not appear on a patient's medical records, and how these restrictions put patients' lives at risks due to hiding information about patient care outside the hospital patient management systems.

PET would like to thank the sponsors of its conference - the Anne McLaren Memorial Trust Fund, the Edwards and Steptoe Research Trust Fund, ESHRE, Wellcome, the European Sperm Bank, Ferring Pharmaceuticals, the London Women's Clinic, Merck, Theramex, Vitrolife and the Institute of Medical Ethics.

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The Impact of COVID-19 on the Fertility Sector - BioNews